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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Natus - 00382830048453

Natus Quantum Amplifier system – 64 channels (phase II)
XLTEK
PK1258
In Commercial Distribution

  • 00382830048453 ()


  • Electroencephalograph

NAR - 00842209125159

KIT, QUANTUM ULTIMATE INTENSIVE RESUSCITATION CARRY (Q.U.I.C.K.) - BASIC
NORTH AMERICAN RESCUE, LLC
35-0026
In Commercial Distribution

  • 00842209125159 ()
35-0026

  • Conduction blood/fluid warmer
  • First aid kit, non-medicated, single-use

Mayo Dissecting Scissors - 00192896121928

Mayo Dissecting Scissors Classic Round Blades Straight Quantum
SONTEC INSTRUMENTS, INC.
1100-249Q
In Commercial Distribution

  • 00192896121928 ()

  • Length: 6 Inch
1100-249Q

  • General-purpose surgical scissors, reusable

ACPlus Respiratory Assessment - 00858703006344

Software and sensor to provide assessment of respiratory capabilities.
ACCELERATED CARE PLUS CORP
ARASoftware
In Commercial Distribution

  • 00858703006344 ()


  • Pulmonary function analysis software, interpretive
  • Diagnostic spirometer, professional

16Ch AI BREAST COIL 3T - 04260487680041

No Description
RAPID Biomedical GmbH
10185782 02
In Commercial Distribution

  • 04260487680041 ()


  • MRI system coil, radio-frequency

PowerLook Tomo Detection (ProFound AI) - 00858012005939

No Description
Icad, Inc.
V2
Not in Commercial Distribution

  • 00858012005939 ()


  • Basic diagnostic x-ray system application software

Change Healthcare Anatomical AI™ - 17540262150018

No Description
Change Healthcare Canada Company
1.0.0
In Commercial Distribution

  • 17540262150018 ()


  • Radiological PACS software

Sontro Self-Fitting OTC Hearing Aids - 00850016231116

BEIGE/990011-SWH; set of Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990011-SWH
In Commercial Distribution

  • 00850016231116 ()


  • Air-conduction hearing aid, receiver-in-canal

Sontro Self-Fitting OTC Hearing Aids - 00850016231024

GREY/990002-SWH; set of Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990002-SWH
In Commercial Distribution

  • 00850016231024 ()


  • Air-conduction hearing aid, receiver-in-canal

OrthoGrid Hip Trauma - 00860003424841

OrthoGrid Trauma AI for non-invasive software system that provides image analysis tools for trauma procedures
Orthogrid Systems, Inc.
2010-915-507
In Commercial Distribution

  • 00860003424841 ()


  • Orthopaedic fluoroscopic grid software
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